Linear IgA Bullous Dermatosis

JJP Biologics announces the start of the MAD part in the ongoing Phase I Clinical Trial of a new investigational medicinal product JJP-1212, a first-in-class CD89 antagonist in healthy volunteers, to complete the safety and PK/PD assessment. February 18, 2025 Warsaw, Poland – JJP Biologics, a Polish innovative biopharmaceutical company focused on developing novel therapies for autoimmune and oncological diseases, announces the initiation of the Multiple Ascending Dose (MAD) part of its Phase I clinical trial for JJP-1212. This milestone marks a step forward in the development of JJP-1212 for the treatment of autoimmune and fibrotic diseases. The Phase I trial (EU trial number: 2023-508661-33-00) is a randomized, double-blinded, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacometrics, of a new investigational medicinal product JJP-1212 in healthy adult volunteers. The study is divided into a single ascending dose (SAD) part and multiple ascending dose (MAD) part. The MAD part of the trial will assess the safety parameters of three subsequent administrations of JJP-1212 in two dosing cohorts. This part of the study will deliver valuable clinical information on safety profile, pharmacokinetic and pharmacodynamic data of JJP-1212. “The MAD part of our Phase I is critical to determine the safety of JJP-1212 over prolonged periods and repetitive dosing that might be needed to treat certain chronic autoimmune and/or fibrotic indications. Therefore, we are delighted with the decision of the dose escalation committee to continue to our first MAD cohort. ” said Louis Boon, Chief Scientific Officer and Board Member at JJP Biologics. About JJP-1212 JJP-1212 is a first-in-class anti-CD89 antagonist IgG4-κ monoclonal antibody that inhibits immunoglobulin A (IgA) mediated activation of myeloid cells. The presence of IgA-containing immune complexes or IgA tissue deposits has been associated with the progression and severity of various autoimmune and fibrotic diseases. JJP Biologics is developing a companion diagnostic for various indications using serum IgA autoantibodies as biomarkers to stratify patients for personalized treatment with JJP-1212. The European Medicines Agency granted JJP-1212 the orphan designation (EU/3/22/2702) for the treatment of linear IgA dermatosis patients (LAD). With the recent phase I clinical trial authorization by the Office for Registration of Medicinal Products in Poland, JJP-1212 became the first new biologic treatment in the history of the Polish biotechnology sector to enter the clinical phase. The JJP-1212 project is co-financed from the state budget by the Polish Medical Research Agency (No: 2022/ABM/05/00011). JJP Biologics JJP Biologics is a privately funded, clinical stage biotechnology company that specializes in the development of therapeutic monoclonal antibodies accompanied by companion diagnostics for personalized treatments. JJP Biologics pursues the development of its own product candidates as well as projects executed in cooperation with scientific partners. By targeting specific immune pathways, the company’s products have broad applications in autoimmune diseases and cancer. JJP Biologics’ current product pipeline includes the most advanced JJP-1212, a first-in-class anti-CD89 antagonizing monoclonal antibody for the treatment of various autoimmune and fibrotic diseases, and JJP-1008, a first-in-class CD270 immune checkpoint inhibiting monoclonal antibody, for the treatment of various oncological indications. For further information, please contact: info@jjpbiologics.com Follow us on LinkedIn: Be a smart goose https://lnkd.in/eZV3ZbS9 Download as PDF file >>

JJP Biologics announces a positive recommendation from the Phase I Dose Escalation Committee to move to second cohort in the ongoing single ascending dose (SAD) part of its Phase I Clinical Trial of JJP-1212 in healthy volunteers, followed by a multiple ascending dose (MAD) part to complete the safety and PK/PD assessment. August 28, 2024 August 28, 2024 Warsaw, Poland – JJP Biologics, a clinical-stage innovative biotechnology company, has started Phase I Clinical Trial of a potential first-in-class anti-CD89 antagonist, JJP-1212, monoclonal antibody for the treatment of various IgA-mediated autoimmune and fibrotic diseases. JJP Biologics, after receiving positive decision on the clinical trial in May 2024 (EU CT number: 2023-508661-33-00), started the study that is designed as single center trial carried out in Poland with 48 healthy adult volunteers, divided into 6 dosing cohorts. The study endpoints are designed for a comprehensive evaluation of the treatment’s safety profile. The drug candidate JJP-1212 is administered intravenously in single and multiple ascending dose cohorts. “Proud, grateful and excited” as mentioned by Louis Boon Ph.D., CSO of JJP Biologics, the 3 words that perfectly describe his state-of-mind. “I perfectly remembered my first conversation with Prof. Marjolein van Egmond, in which she convinced me about CD89 as an interesting target for autoimmune and fibrotic diseases. Now, here we are a few years later and the clinical testing of JJP-1212 has been initiated”. This shows the commitment in JJP Biologics’ journey to bring new and safe treatment options to patients suffering from pathogenic IgA antibodies. About JJP-1212 JJP-1212 is a first-in-class IgG4-κ anti-CD89 antagonist that is being developed to treat autoimmune and fibrotic diseases in which IgA autoantibodies are a key element of the disease pathophysiology. Alongside Linear IgA Dermatosis (LAD), JJP-1212 is being developed for a wide range of autoimmune- and fibrotic diseases where IgA is known to have significant pathogenic involvement (e.g. rheumatoid arthritis, axial spondyloarthritis, systemic lupus erythematosus, neutrophilic asthma, chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, cystic fibrosis, hidradenitis suppurativa, nonalcoholic steatohepatitis, IgA nephropathy, IgA vasculitis). JJP Biologics is exploring the development of companion diagnostics in various indications using serum IgA autoantibodies as biomarkers for personalized treatment with JJP-1212. The European Medicines Agency (EMA) granted JJP-1212 the orphan designation (EU/3/22/2702) and subsequently the Office for Registration of Medicinal Products in Poland authorized the Phase I Clinical Trial in healthy volunteers. With this JJP-1212 is the first New Biological Entity in the history of the Polish biotechnology sector, completely discovered and developed in Poland. The JJP-1212 project is co-financed by the state budget by the Polish Medical Research Agency (No: 2022/ABM/05/00011). JJP BIOLOGICS JJP Biologics is a privately funded, clinical stage biotechnology company that specializes in the development of therapeutic monoclonal antibodies accompanied by companion diagnostics for personalized treatment. JJP Biologics pursues the development of its own product candidates as well as projects executed in cooperation with scientific partners. The company’s programs target general immune pathways that have applications in autoimmune diseases and cancer. JJP Biologics current range of programs includes the most advanced JJP-1212, a potential first-in-class anti-CD89 antagonist for (auto)inflammatory diseases, and JJP-1008, a potential first-in-class CD270 checkpoint inhibitor, for solid tumors. Warsaw, Poland About JJP-1212 JJP BIOLOGICS For further information, please contact: info@jjp.bio Follow us on LinkedIn: Be a smart goose https://lnkd.in/eZV3ZbS9 info@jjp.bio https://lnkd.in/eZV3ZbS9 Download as PDF file >> Download as PDF file >>

JJP Biologics has received a positive conclusion on the Clinical Trial Application assessment for a Phase I Study of a potential first-in-class anti-CD89 antagonist, JJP-1212 monoclonal antibody for the treatment of various IgA-mediated autoimmune- and fibrotic diseases. Warszawa Wednesday, May 29, 2024 On May 27, 2024 the European Medicines Agency, issued a positive decision on our first Clinical Trial Application to conduct a phase I clinical study in healthy participants (EudraCT: 2023-508661-33-00) with a potential first-in-class anti-CD89 antagonist, JJP-1212 monoclonal antibody for the treatment of various IgA-mediated autoimmune- and fibrotic diseases. Up to date, JJP Biologics is the first Polish company to receive approval to perform the First-in-Human clinical trial with a novel therapeutic monoclonal antibody. This decision is an important milestone for patients suffering from IgA-mediated autoimmune or fibrotic diseases and validates the preclinical package of JJP-1212. The phase I trial will be carried out in Poland. The study endpoints are designed for a comprehensive evaluation of the treatment’s safety profile. The drug will be administered via intravenous infusion in single and multiple ascending dose cohorts. Population size was determined as 48 healthy adult volunteers. The study results will provide data on the safety and tolerability of JJP-1212, and full PK/PD profiles that subsequently enable the determination of optimal treatment regimens in future studies with patient populations. JJP Biologics intends to use phase I read-outs as supporting data for a set of phase II trials, in a range of therapeutic areas, and regions (including EU and the US). The expected study results will not only validate the safety but also contribute to deciding on extension of JJP-1212’s development scope in various therapeutic areas, beyond dermatology. According to Paweł Szczepański, COO and Management Board Member at JJP Biologics – “This is a historically unprecedented approval of a first-in-human clinical trial for a novel large molecule therapy from Poland. It forms a landmark that will further strengthen the position of the Polish biotech sector on the global map blazing the trail for many innovative therapies to come from this part of Europe. Including the next ones from the development platform of JJP Biologics”. JJP-1212 is a first-in-class IgG4-κ anti-CD89 antagonist that is being developed to treat autoimmune and fibrotic diseases in which IgA autoantibodies are a key element of the disease pathophysiology. Alongside Linear IgA Bullous Dermatosis (LABD), JJP-1212 is being developed for a wide range of autoimmune- and fibrotic diseases where IgA is known to have significant pathogenic involvement (e.g. rheumatoid arthritis, axial spondyloarthritis, systemic lupus erythematosus, neutrophilic asthma, chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, cystic fibrosis, hidradenitis suppurativa, nonalcoholic steatohepatitis, IgA nephropathy, IgA vasculitis). JJP Biologics is exploring the development of companion diagnostics in various indications using serum IgA autoantibodies as biomarkers for personalized treatment with JJP-1212. JJP BIOLOGICS JJP Biologics is a clinical-stage biotechnology company that specializes in the development of therapeutic monoclonal antibodies accompanied by companion diagnostics for personalized treatment. JJP Biologics pursues the development of its product candidates as well as projects executed in cooperation with scientific partners. The company’s programs target general immune pathways that have applications in autoimmune diseases and cancer. JJP Biologics’ pipeline includes the most advanced JJP-1212, a potential first-in-class anti-CD89 antagonist for the treatment of autoimmune- and fibrotic diseases, and JJP-1008, a potential first-in-class anti-CD270 checkpoint inhibitor, for solid tumors. The JJP-1212 Project is co-financed by the state budget by the Polish Medical Research Agency (No: 2022/ABM/05/00011). JJP Biologics is a privately funded biotech, partially financed from programs run by the Polish Medical Research Agency. In 2022, JJP Biologics became the first Polish company whose biological drug candidate (JJP-1212) received an Orphan Drug Designation from the European Commission, following the recommendation of the European Medicines Agency. Download as PDF file >>